ATMOS® i View PRO
GA1GB.120102.0
2018-04 Index: 17
Operating Instructions
English
2
Table of contents
Further information, accessories, consumables and spare
parts are available from:
ATMOS
MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Straße 16
79853 Lenzkirch
Germany
Phone: +49 7653 689-0
Fax: +49 7653 689-190
+49 7653 689-292 (Service Centre)
atmos@atmosmed.de
www.atmosmed.com
4.5 Adjusting the eye pieces .....................................16
4.6 Exchanging the lenses ........................................17
4.7 Exchanging the lenses with manual ne
focusing...............................................................17
4.8 Exchanging the VarioFocus lens .........................17
4.9 Adjustment of the 5 fold magnication changer ..17
4.10 Focussing............................................................18
4.10.1 Fine focussing .....................................................18
4.11 Exchanging the binocular tube............................18
4.12 Binocular rotary disk with detent .........................18
4.13 Pivoting colour lter.............................................18
4.14 Shadowless illumination......................................19
4.15 Microscope zoom and object eld size ...............19
4.16 Measuring scale ..................................................19
4.17 Image and video recording .................................20
4.17.1 Adjusting the light mode of the integrated HD
camera ................................................................20
4.18 Endoscope adapter .............................................21
4.19 HD adapter..........................................................21
5.0 Cleaning and care .............................................22
5.1 General information on cleaning
and disinfection ...................................................22
5.2 Cleaning the mechanical microscope surface ....22
5.3 Cleaning of lenses / eyepieces ...........................22
5.3.1 Cleaning optical surfaces ....................................22
5.3.2 Optical surface of the endoscope port ................22
5.3.3 Fogging of optical surfaces .................................23
5.4 Recommended surface disinfectants ..................23
5.5 Hygiene plan .......................................................23
6.0 Maintenance and Service .................................24
6.1 Basic instructions ................................................24
6.2 Sending in the device..........................................24
6.3 Exchange of spare parts .....................................24
7.0 Troubleshooting ................................................25
8.0 Accessories and Options .................................26
9.0 Technical data ...................................................27
10.0 Disposal .............................................................28
11.0 Notes on EMC ....................................................29
1.0 Introduction .........................................................3
1.1 Notes on operating instructions ............................3
1.2 Intended use .........................................................4
1.3 Function ................................................................5
1.4 Explanation of pictures and symbols ....................6
1.5 Scope of supply ................................................... 7
1.6 Transport and storage ...........................................7
2.0 For your safety ....................................................8
3.0 Setting up and starting up .................................9
3.1 Overview .............................................................. 9
3.2 Setting up ............................................................10
3.2.1 Connection to the mains supply ..........................10
3.2.2 Microscope overview ..........................................10
3.2.3 Operating elements at the microscope ............... 11
3.2.4 Rear view of the control device
ATMOS
®
i View 21 PRO......................................11
3.2.5 Rear view of the control device of the
ATMOS
®
i View 31 PRO
(not with an integrated HD camera) .................... 11
3.2.6 Rear view of the control device of the ATMOS
®
i
View 31 PRO with an integrated HD camera .....12
3.3 Integration possibilities........................................12
3.4 Starting up...........................................................13
3.5 Operation requirements ......................................13
3.6 Starting up at a glance ........................................14
4.0 Operation ...........................................................15
4.1 Microscope suspension ......................................15
4.2 Mechanical arm...................................................15
4.3 Hand grips...........................................................15
4.3.1 T-hand grip ..........................................................15
4.3.2 Lateral double hand grip .....................................15
4.4 Adjusting the interocular distance .......................16
3
1.0 Introduction
1.1 Notes on Operating Instructions
These operating instructions contain important notes on how to operate the ATMOS® i View PRO safely,
correctly and effectively. Their reading helps to avoid risks, and also to reduce repair costs and downtimes. This increases, amongst other things, the reliability and service-life of the microscope.
These operating instructions serve not only for new operating personnel to be instructed in its use, but
also for use as a reference manual. Reprints (also in extracts) only with permission in written form by
ATMOS.
These operating instructions must always be kept available near the device.
Care and safety inspections in conjunction with professional execution provide for operational safety and
readiness for use of your ATMOS
®
i View PRO and are therefore a must besides regular cleaning.
Repair work and safety inspections may be carried out only by expert personnel authorised by ATMOS.
By applying only original spare parts you will have the guarantee that operational safety, readiness for
work and the value of your ATMOS
®
i View PRO will be preserved.
• The product ATMOS
®
i View PRO bears CE marking CE according to the EC Directive of the council
for medical products 93/42/EEC and meets the basic requirements of Appendix 1 of this directive.
• The product ATMOS
®
i View PRO complies with all applicable requirements of the Directive 2011/65/
EU restricting the use of certain hazardous substances in electrical and electronic equipment
(„RoHS“).
• The declaration of conformity and our general standard terms and conditions can be obtained on our
website at www.atmosmed.com.
• The quality management system applied at ATMOS has been certied according to international
standards EN ISO 13485.
• Prior to start-up please peruse chapter 2.0 „For your safety“, in order to be prepared for any possible
dangerous situations.
Please keep this document for future consultation!
These operating instructions are valid for the following
devices:
ATMOS
®
i View 21 PRO ............................. REF 538.9000.0
Examination microscope with an integrated, fanless, high
transmission, high performance LED light source integrated in
the microscope head, 30° coupling included
ATMOS
®
i View 31 PRO ............................. REF 539.9000.0
Examination microscope with an integrated, fanless, high
transmission, high performance LED light source integrated in
the microscope head, 30° coupling included
4
1.2 Intended use
Name:
ATMOS
®
i View 21 PRO
ATMOS
®
i View 31 PRO
Main functions:
Optical instrument for magnication and illumination of the mouth to the pharynx, the auditory canal to the ear drum, the
middle ear and the nasal cavities. It can be used for observation and documentation as well as for the treatment of humans.
Medical indications / application:
Standard ENT examination for visual inspection in the eld of ENT and surgical interventions
Specication of the main function:
The application organ is illuminated for examination purposes and can be visualized on a monitor if desired by an integrated,
fanless high transmission, high performance LED light source, 5-step magnication changer, integrated camera module,
pivoting colour lter and an automatic light control via tilt sensor; the light output is min. 120 kLux (200 mm), min. 80 kLux
(250 mm), min. 55 kLux (300 mm), min. 30 kLux (400 mm) with a colour temperature of 5.500 K ± 10 %.
User prole:
Examinations and surgical interventions which are carried out using the microscope may only be performed by doctors with
appropriate training.
Only qualied personal with a proper hygiene training may prepare the microscope for surgical interventions.
Installation and maintenance may only be carried out by service technicians who were trained and authorised by the
manufacturer.
Patient groups:
No restrictions
Application organ:
Mouth to pharynx, auditory canal to the ear drum the middle ear and the nasal cavities
Application time:
Short term use on the patient (up to 30 days)
Application site:
Application sites are clinics, practices and operating rooms for ENT doctors and phoniatrists as well as temporal bone
laboratories. The examination with the microscope may only be executed by medically trained persons.
The microscope may only be used in closed rooms, on rm ground, wall-mounted, ceiling-mounted or mounted to ATMOS
ENT units.
In ORs an appropriate protective sleeve must be used.
Contraindications:
• No application in ophthalmology.
• Do not use the ATMOS
®
i View PRO on seated patients in combination with an objective (focal length of 200 mm to
300 mm).
The product is:
active
Sterility:
The microscope is not a sterile product.
Single-use product / reprocessing:
The microscope is intended for multiple use. The device and part of the accessories are reusable. For information on
reprocessing and disinfection, please see the operating instructions.
1.0 Introduction
5
1.0 Introduction
1.3 Function
The ATMOS® i View PRO is a complete microscope system, consisting of optics and lighting. It produces outstanding pictures for
examination purposes with the use of latest LED technology and patent registered optics. The interaction between the integrated
fanless, high transmission, high performance LED, the apochromatic optics and the precisely tting options offer best working
quality.
The ergonomically assorted buttons, two selectable hand grips and the integrated control panel provides the user with highest
level of ergonomic comfort and suitability for daily use as well as an outstanding and intuitive handling. Via the control panel the
individual options of the ATMOS
®
i View PRO can be activated. Besides the triggering of the camera (freeze frame) and starting
/ stopping of possible video sequences, the operator is capable of manually switching the LED light source on and off despite the
activated automatic light control. Due to the variety of options which the ATMOS
®
i View PRO has to offer, the user is in a position to
congure a microscope to suit his requirements. The following functions can be chosen optionally:
• 4 lenses with different focal distances (200, 250, 300 and 400 mm) with or without ne focussing or a VarioFocus 200-350 mm
(easy exchange of the lenses due to the respective thread on the microscope head)
• Binocular straight lens tube, binocular angled lens tube and binocular swivel tube, simple adaption due to the dove tail xation
(0° or 45° angled)
• Pivoting colour lter
• Measuring scale
• Shadowless illumination
Due to the LED light source and the integrable camera solution (SD or HD integrated respectively as HD or endoscope adapter for
the connection of an external camera) the ATMOS
®
i View PRO is a guarantor for best image quality.
In connection with the mechanical support arm and the numerous connection possibilities to units and stands the ATMOS
®
i View
PRO offers countless system possibilities, which can be individually adapted to suit the users environment!
These operating instructions describe all functions at maximum conguration of the ATMOS
®
i View 31 PRO.
6
1.4 Explanation of pictures and symbols
1.0 Introduction
!
■
●
Graphic symbols contained in these operating instructions
Warning, special diligent notice
Short cuts / symbols contained in these operating instructions
Please press where dot
indicates
Numeration
General information
Follow the arrows
Replace
Check
Please read,
important information
Move, plug... in this
direction
Engage, check
correct t
Turn, shift... in this
direction
Important information
Symbols ATMOS
®
i View PRO
SN Serial number
REF
Order number
Manufacturing date Manufacturer
Observe operating instructions! Observe operating instructions!
Weight adjustment for the carrier arm Professional disposal
Alternating current Fuse
2
Single use product - not for reuse.
Exchange after use.
This product complies with the relevant
requirements of EU Directives
Do not look directly into the light
source of the ATMOS
®
i View
The carrier arm of the mobile stand must be
brought into a position suitable for transport.
Do not lean against the device.
Control panel ATMOS
®
i View 31 PRO
Light on / off (independent of automatic light
control)
Change between stroboscope - permanent light
With an integrated HD camera: Adjusting the light
mode of the camera
Video recording (start / stop) Freeze frame
click
7
1.0 Introduction
1.5 Scope of supply
• Prior to dispatch, the ATMOS® i View PRO was subjected to an extensive functional test and was carefully packed.
Nevertheless, please compare the contents of the shipment on completeness immediately upon receipt (see delivery note).
1.6 Transport and storage
• After the transport of the ATMOS® i View PRO in
temperatures below 0°C or prior to rst start up it
should be kept at room temperature for at least six
hours. If the ATMOS
®
i View is not acclimatized it may
not be used as damages to the electronic components
could occur.
Only transport the device in a shipping carton, which is
padded and offers sufcient protection.
If damage occurs during transport:
• Document and report the transport damage.
• Send the device to ATMOS (Chapter „6.2 Sending in
the device“ on page 24).
Ambient conditions:
• Transport / storage:
- -10...+50 °C;
- 30...95 % humidity no condensation
- at an air pressure of 500...1060 hPa
• Operation:
- +10...+35 °C;
- 30...95 % humidity no condensation
- at an air pressure of 700...1060 hPa
Microscope
Operating
Instructions Protective cover
Microscope arm
Control device ATMOS® i View 21 PRO
Output of the power supply for the
electronics in the microscope
Potential equalisation acc. to IEC 604175021
Fuse
Control device ATMOS® i View 31 PRO
Fuse Potential equalisation acc. to IEC 604175021
Microscope Foot switch
Record function Freeze
Triggering signal from ATMOS® Strobo 21
LED
HD camera: not in use
Output signals of the tilt sensor in the carrier arm
system
USB port
Extern 2
Video In
Foot Switch
Out 1
Out 2 Out 3
Video Out
Intern 1
Video In
Input video signal Internal / External
(only with an integrated HD camera)
S-video-output
(not with an integrated HD camera)
Foot Switch
Out 1
Out 2 Out 3
Video Out
Output video signal
(only with an integrated HD camera)
8
2.0 For your safety
!
For your safety
mains power supply.
• Only proper and undamaged plugs and extension cables
may be used.
• To disconnect the ATMOS
®
i View PRO from the power
supply, the power cable must be removed from the wall
outlet. Only then can the connection cable from the
ATMOS
®
i View PRO be disconnected. Never touch plug
or line with wet hands.
• Please observe the ambient conditions stated in the
technical data (chapter 9.0).
• The ATMOS
®
i View PRO complies with the
electromagnetic immunity requirements of standard IEC
60601-1-2 / EN 60601-1-2 „Electromagnetic Compatibility Medical Electrical Devices“.
• ATMOS is not liable for personal injury and damage to
property if
- no original ATMOS parts are being used,
- the advice for use in these operating instructions is not
being observed,
- assembly, new settings, alterations, extensions
and repairs have been carried out by personnel not
authorised by ATMOS.
• Unplug the device immediately if you observe fumes,
sparks or weird noises.
• After a longer use of the ATMOS
®
i View PRO in
connection with an ear speculum the patient may feel
dizzy!
• With every light source a warming of tissue due to
absorption may occur. Please make sure to reduce
duration of use to a minimum, to switch off the light
source when not in use and to check heat development if
necessary.
• Take into consideration, when setting up the microscope,
that the elastic force of the arm – without microscope head
– is exceedingly strong. Operate the break of the height
adjustment carefully.
• Risk of injury! Take care not to roll the mobile stand over
your feet when moving the stand.
• Please note that only PCs and monitors with IEC 6060101/EN 60601-1 approval may be connected to the video
outlet of the ATMOS
®
i View PRO supply module!
• During operation, the user is obliged to regularly check
the microscope for proper function. In the unlikely event
of failure the user must take precautions to continue the
treatment of the patient with suitable methods.
• Make sure that the unit is positioned so that all the controls
and the on/off switch are always accessible.
• To safely disconnect the unit from the mains, the power
cord must be removed from the IEC connector of the
control device!
• The ATMOS
®
i View PRO is a device designed in line with
IEC 60601-1-1/EN60601-1 and it is a device with protection
class I. In order to avoid the RISK of electrical shock, this
unit may only be connected to a mains supply with properly
installed earth conductor.
• Power cables, accessories and access cables need to be
checked for defects prior to setting up the ATMOS
®
i View
PRO. Defect cables must be replaced immediately.
• The ATMOS
®
i View PRO may only be operated by qualied
personnel.
• The ATMOS
®
i View PRO is not designed to be used
in an explosion-hazardous environment. Explosion-
hazardous areas may be caused by the use of ammable
anaesthetics, skin cleansing products and skin
disinfectants.
• The ATMOS
®
i View PRO may be operated only in rooms
used for medical purposes, but not in areas subject to
explosion hazards and in oxygen rich environments.
• If uids penetrated the ATMOS
®
i View PRO it needs to
be sent in and may only be used after the check up of an
ATMOS authorised person.
• After the transport of the ATMOS
®
i View PRO in
temperatures below 0°C or prior to rst start up it should
be kept at room temperature for at least six hours. If the
ATMOS
®
i View PRO is not acclimatised it may not be used.
• Do not plug in electric connections (plug, socket) under
the use of force. If this is not possible check whether the
plug ts the socket. If you should ascertain a defect in the
connection you should have it repaired by our service.
• Never look straight into the sun with lenses or eye lenses.
• Always make sure that you do not blind patients with the
light source! Watch out that patients do not look directly into
the light source!
Never look directly into the light source!
> Damage to the eyes due to the strong glare.
• Please pay attention to the period tests in chapter 6
„Service and maintenance“ on page 24.
• Prior to every use the microscope suspension (all joints
included) need to be checked for safe connections.
• Take care that the patient does not touch the device or have
any contact with it.
• Please note that only the ATMOS
®
Strobo 21 LED may be
connected to the strobe port of the ATMOS
®
i View PRO!
• Please observe the EMC Directives. Failure to follow this
guideline can result in a hazard.
• Dispose of wrappings accordingly.
• Before connecting the ATMOS
i View PRO it needs to
be checked whether the requested mains voltage of the
ATMOS
®
i View PRO matches the mains voltage of the
9
3.0 Setting up and starting up
3.1 Overview
ATMOS® i View 21 PRO ATMOS® i View 31 PRO
Description
Examination microscope with an integrated,
fanless, high transmission, high performance
LED light in the microscope head
Examination microscope with an integrated,
fanless, high transmission, high performance
LED light in the microscope head
Integrated high
performance white
light LED
Automatic light
control
Optimised
stereo effect
Measuring scale optional optional
Integrated operating
panel
optional optional
Stroboscope mode - optional
Colour lter optional optional
Integrated camera -
optional SD camera or
optional HD camera
45° angled tube optional optional
Swivel tube 0-220° optional optional
Binocular rotary disk optional optional
HD adapter for an
external camera
- optional
Endoscope adapter - optional
Mains voltage 100–240 V 100–240 V
Light output
min. 120 kLux (200 mm)
min. 80 kLux (250mm)
min. 55 kLux (300 mm)
min. 30 kLux (400 mm)
min. 120 kLux (200 mm)
min. 80 kLux (250mm)
min. 55 kLux (300 mm)
min. 30 kLux (400 mm)
Operating life of the
LED
50,000 hours 50,000 hours
Colour temperature 5.500 K ± 10 % 5.500 K ± 10 %
Scope of delivery
Dust cover,
operating instructions
Dust cover,
operating instructions
10
3.0 Setting up and starting up
5-fold magnication changer
T-hand grip
(optional)
Binocular tube with wide
eld eyepiece lenses
Lens with ne focussing
(optional)
Pivoting colour lter
(optional)
Brightness control
Lateral double hand
grip (optional)
Control panel
(optional)
Endoscope adapter
(optional)
HD adapter for SONY
digital camera (optional)
Brake of the
coupling
Measuring scale
(optional)
3.2 Assembly
Please make sure that the static conditions stated by ATMOS MedizinTechnik are met (for details see the separately enclosed
document „Static requirements for installing the ATMOS i View“). The fullment of these requirements must be conrmed by an
authorized expert.
Mains voltage and fuse: Mains voltage: 100-240 V; 50/ 60 Hz, fuse: 2 x T 3.15 A
Please note that only PCs and monitors with IEC 606010-1/EN 60601-1 approval may be connected to the video outlet of the
ATMOS
®
i View PRO supply module!
Please note that only the ATMOS
®
Strobo 21 LED may be connected to the strobe port of the ATMOS® i View PRO!
3.2.1 Connection to the mains supply
Potential equalisation:
The ATMOS
®
i View supply module has a rear connection for potential equalisation which can be connected to the potential
equalisation rail in the room if need be. Hereby user/patient safety can be increased especially in the case of a defective earth
conductor. For connecting the device's potential equalisation plug with the potential equalisation rail of the room, use the potential
equalisation cord with REF 530.0030.0.
3.2.2 Microscope overview
!
11
MODE
LED
AFD
STROBO
LED STROBO AFD
3.0 Setting up and starting up
Output of the power supply
for the electronics in the
microscope
Connection for potential
equalization performance acc. to
IEC 60417-5021
IEC power plug with fuse inlay
for the connection to the mains
power supply
3.2.4 Rear view of the control device of the ATMOS® i View 21 PRO
3.2.3 Operating elements at the microscope
Mode display
“permanent light“
Mode display
“stroboscope“
Video
recording
(start / stop)
Freeze
frame
Display of the „permanent light“ mode - by pressing
the MODE button a single time, the „permanent light“
mode can be switched on.
Display of the „stroboscope“ mode - by pressing
the MODE button again, the mode switches from
„permanent light“ to „stroboscopy“. In this mode
the integrated LED is controlled by the connected
ATMOS
®
Strobo 21 LED.
Light on / off
(independent of
automatic light
control)
Switch stroboscope - permanent light
With an integrated HD camera:
Adjusting the light mode of the camera
USB port for the transfer
of the key status of
the „Freeze frame “and „Video recording
-functions“.
Output signal of
the „video record
function“
Output signal of
the „Freeze frame
- function“
Output signals of
the tilt sensor in the
carrier arm system
Output of the triggering
signal of the ATMOS
®
Strobo 21 LED
S-Video-output of
the integrated SD
camera
Connection for
the supply to
the microscope
electronics and control
performance.
Connection to the foot switch
for switching between the light
channels
Connection for potential
equalization performance
acc. to IEC 60417-5021
IEC power plug with fuse inlay
for the connection to the mains
power supply
3.2.5 Rear view of the control device of the ATMOS® i View 31 PRO (not with an integrated HD camera)
12
060.0604.0
Schild Transportst. Mikolp
Label transport position Mikolp
1:1
OEI
24.07.13
O.Eirich
Blatt
(sheet)
1
Bl.1/1
Name
(name)
Maßstab (scale)
Konstr. Nr.
Gepr.
Bearb.
Name
Erstellt
Datum
Ers.f. :
Ers.d. :
Benennung (description)
Zeichnungs /
Artikel-Nr.
(part no.)
Alle Maße in mm/
all dimensions in mm
Allgemeintoleranzen /
General tolerances
DIN ISO 2768 - mK
79853 Lenzkirch / Germany
MedizinTechnik
atmos@atmosmed.de
ATMOS Medizin T echnik GmbH & Co. KG
Ludwig - Kegel - Str. 16
Tel: +49 7653 689 -0
Fax: +49 7653 689 -190
www.atmosmed.de
A4
3M Folie7876EC+Laminat 7730FL
weiß
transparent
RAL 5005 Signalblau
RAL 3001 Signalrot
schwarz
OEI
C.Reinhardt
09.01.14
09.01.14
C.Reinhardt
3.0 Setting up and starting up
!
3.2.6 Rear view of the control device of the ATMOS® i View 31 PRO with an integrated HD camera
Sensor
Strobo
Extern 2
PC/USB
Video In
Record
Freeze
Foot Switch
Out 1
Out 2 Out 3
Video Out
Microscope
Intern 1
Video In
2 x T 3,15A
100 - 240V~
PC connection
(optional)
Output signal of
the „Video record
function“
Output signal of
the „Freeze frame
function“
Output signals of
the tilt sensor in the
carrier arm system
not in use
HD video outlet from the
video source internal 1 or
external 2
HD video input. Can
only be used for the HD
camera module
HD video input from
an external HD
video source
Connection for
the supply of
the microscope
electronics
and the control
performance.
Connection to the foot
switch for switching
between the light
channels
IEC power plug with fuse
inlay for the connection
to the mains power
supply
Connection for
potential equalization
performance acc. to IEC
60417-5021
3.3 Integration options
Please note the assembly instructions for the integration options.
Mobile stand PRO
When moving the roller stand please make sure that the microscope arm is in a retracted position and the
screws are tightened.
Risk of injury! Take care not to roll the mobile stand over your feet when moving the stand.
When the device is placed in the working position the brakes must be locked.
Only monitors which do not exceed the following specications can be adapted to the mobile stand.
Maximum dimensions H x W x D: 60 x 40 x 10 cm, weight: 9.8 kg
The stability of the mobile stand cannot be guaranteed for monitors which do not match these specications.
Wall stand
Afx to wall by use of a guide rail. The mounting of the microscope head is height adjustable.
Recommendation: Please use a water level to align the wall stand!
Ceiling mount
Mounting with mounting plate and pipe system on the ceiling. The structural requirements must be met.
The ceiling mount is suitable for receiving the ATMOS
®
i View PRO and a monitor up to 10.5 kg.
Only the supply module of the ATMOS
®
i View PRO and the monitor may be connected to the power supply of the ceiling mount.
Risk of injury! Do not burden the ceiling support with additional weight. Do not lean against the carrier arm or microscope and do
not hang any objects on it. The ceiling mount can otherwise crash and you or patients can be seriously injured!
!
13
3.0 Setting up and starting up
3.4 Starting up
• Remove the microscope from the packaging. Check whether the mains current on the type label corresponds to the mains
power supply.
• Check the scope of delivery.
• Peruse safety information in part 2.0 prior to starting up the device for the rst time.
• After the transport of the microscope in temperatures below 0°C it must be kept at room temperature for at least six hours. If the
microscope is not acclimatized it must not be used.
• Consider, when setting up the microscope, that the elastic force of the arm – without microscope head – is exceedingly strong.
Operate the break of the height adjustment carefully.
• To activate the ATMOS
®
i View PRO please use the power switch on the front side of the control device.
3.5 Operating requirements
Please note that following the installation of the device, the following requirements are met for further operation of the device:
• All joints and connection parts which are responsible for the safety of the device are securely fastened.
• All electronic connections (cables, plugs, power cables etc.) are in good order and condition.
• The specied mains voltage and frequency on the microscope corresponds to the supply network.
• The microscope is connected to a safety connection socket with the provided mains cable.
Attention, never point or direct the beam into the patients eyes. Do not look directly into the light source.
• With every light source a warming of tissue due to radiation and absorption could occur. This could result in
damage to the biological tissue. Please keep the luminosity and duration of use to a minimum. Switch off the
light source when not in use and check the heat development if necessary.
!
14
3.0 Setting up and starting up
3.6 Starting up at a glance
Adjust microscope to initial position on the microscope suspension by use of the xing wheel.
Adjust microscope horizontally and vertically.
Adjust all the clamps on the carrier and oat arm to secure the movability of the arm in compliance with
the requirements.
Swing in microscope into the working space.
Adjust the interocular distance by pressing or pulling the lens tubes together or apart. The interocular
distance is perfectly adjusted when you look through and a circular picture is perceived!
Adjusting the eyepieces.
Persons without glasses Persons with glasses
Eyepieces remain in initial
position (eyepieces are pulled
out). Dioptre scale adjusted to
zero
People with defective vision
and glasses
People with defective vision
without glasses (refraction
values known)
People with defective vision
without glasses (refraction
values unknown)
Keep glasses on, push
eyepieces in direction of the
lens tube until they engage
audibly. Adjust dioptre scale
to zero.
Remove glasses and adjust
dioptre scale to matching
number (eyepieces are
pulled out).
Remove glasses and adjust
both eyepieces to +5 dpt.
Remove the lens tube from
the microscope head and
focus on an object* in the
distance. The object still
looks blurred. Turn the
dioptre ring of the rst
eyepiece slowly in clockwise
direction until the object
is sharp. Keep your other
eye closed while adjusting
the eyepiece. Repeat this
procedure for a couple
of times to determine an
average value. Adjust
the second eyepiece by
the same procedure and
reattach the lens tubes to the
microscope head with the
connective screw (eyepieces
are pulled out).
* Never use the sun as an
object!
Set the 5-fold magnication changer unit to maximum zoom (2.0). Approach the object with the
microscope (according to the chosen focal distance) until the image is sharp. If the zoom level is
changed the grade of sharpness is retained.
Brightness can be adjusted by the rotary knob on the bottom of the device if necessary.
15
4.0 Operation
Rotating
knob
4.1 Microscope suspension
By means of a corresponding suspension the microscope
head is connected laterally to the microscope arm. The
complete range of cables run through the suspension therefore no disturbing cables are visible from the outside
(with the exception of the connection to the HD adapter and
direct connection to a monitor). Due to a rotating knob, which
is situated on the side of the suspension, the microscope can
be adjusted vertically to suit the individual requirements of
the user. The 30° swivel unit allows to rotate the microscope
head around its own axis and sway it to the side. The
„weightless motion brake“ included into the 30° swivel unit
provides a sensitive, individual adjustment of the motion
strength, so that the microscope head remains in every
position, even with installed accessories and thus enables
you to continue with the examination. To x the microscope
head turn the rotating knob towards you in a clockwise
direction.
To loosen the microscope head turn the rotating knob
towards you counter-clockwise.
Attention: Check the secure connection of the microscope
to the suspension prior to every use!
4.2 Mechanical arm
The mechanical microscope arm can be adjusted via four
set screws according to the individual requirements of the
user. Choose the strength of the clamping so that the free
movement of the arm suits your requirements. Turn the set
screw in clockwise direction to x the arm. To loosen the arm
turn counter-clockwise. To align the arm please observe the
assembly instructions for the integration possibilities.
Attention: Prior to use ensure that the brakes of the support
arm are set correctly.
Automatic light switching: Once the arm is in the upper
position the LED light switches off automatically.
4.3 Hand grips
When purchasing the ATMOS® i View PRO you may choose
between two versions of handles.
4.3.1 T-hand grip
(see gure)
4.3.2 Lateral double hand grip
The position of the lateral double hand grip can be gradually
adjusted by simultaneously pulling and turning the handle
(see gure).
Adjusting screws
16
4.0 Operation
4.4 Adjusting the interocular distance
The interocular distance is adjustable between 50-75 mm.
• Swivel the microscope into the work space.
• Look through the eye lenses and push or pull the eye
lens tubes together or apart with both hands.
The interocular distance is perfectly adjusted when you
look through with both eyes and a circular eld is visible!
4.5 Adjusting the eye pieces
Persons without glasses:
• Eyepieces remain in initial position.
Initial position = The eye steering of the eyepieces are
pulled out.
• Make sure that the zero of the dioptre scale complies
with the index on the eyepieces.
Persons with glasses:
• People with defective vision and glasses keep their
glasses on and push the eyepieces in direction of the
lens tube until they engage audibly. Adjust dioptre scale
to zero.
• People with defective vision (with known refraction
values)should take their glasses off and adjust the
dioptre scale on the eyepieces to the matching number
(the eye steering of the eyepieces are pulled out).
The process of focussing is performed as described in
Chapter 4.9.
• People with defective vision without glasses adjust both
eyepieces to +5 dpt. Remove the binocular tube and
the eyepiece from the microscope head and focus on
a distant object*. The object still looks blurred. Slowly
turn the dioptre ring of the rst eyepiece in clockwise
direction until the object is sharp. The other eye must
remain closed. Repeat this procedure for a couple
of times in order to determine on an average value.
Adjust the second eyepiece by the same procedure.
Reattach the lens tubes to the microscope head with
the connective screw. The process of focussing is
performed as described in Chapter 4.10.
* Never use the sun as an object!
17
4.0 Operation
4.6 Exchanging the lenses
The designated thread on the microscope head allows
for easy exchange and xation of the different lenses.
Due to the integrated screw mount lenses can be
loosened by turning it to the left hand side and xated by
turning it to the right.
4.7 Exchanging the lenses with
manual ne focussing
Mount lens as described above and secure it with the
intermediate screwed ring.
4.8 Exchanging the VarioFocus lens
To loosen the VarioFocus lens from the microscope
head, turn it to the left. To tighten the VarioFocus lens on
the microscope head, turn it to the right onto the thread.
Position the setting dial
The dial can be positioned on either side of the
VarioFocus lens.
Attention! During the process rmly hold the VarioFocus
lens just in case it may loosen itself from the microscope
head and fall off.
Loosen the three grub screws on the lens. Continue
to hold the lens and turn the setting dial in the desired
position. Tighten the three grub screws.
4.9 Adjustment of the 5-fold
magnication changer
The 5-fold magnication changer from ATMOS enables
free range zoom between 0.5x up to 2.0x.
• Select the desired zoom factor by selecting one of the
lateral rotating knobs.
• Pay attention that the chosen zoom factor engages
audibly with the groove.
• Freely adjustable zoom factors: 2.0 - 1.4 - 1.0 - 0.7 -
0.5.
• The magnication which points in the direction of the
eyepieces is the current magnication.
Lens
5 fold magnication
changer
Grub screw
Setting dial
18
4.0 Operation
4.10 Focussing
• Adjust the zoom to maximum (2.0) on the magnication
unit.
• Approach the object with the microscope until the
image is sharp.
• If the zoom level is changed the pre-adjusted degree of
sharpness is still maintained.
4.10.1 Fine-focussing
The optional ne focussing allows for sensitive and
precise focussing in a 17 mm range. Fine focussing is
necessary in order to focus accurately while zooming in.
• Replace the mounted lens with the appropriate lens
for ne focussing (simple mounting due to the screw
mount at the microscope head. Secure with the
intermediate screwed ring).
• Conduct the focussing as described above.
• Adjust focus by use of the lateral adjusting disk.
4.11 Exchanging the binocular tube
The tubes focal distance of 200 mm allows for a
comfortable and fatigue-proof observation of the object
with both eyes. Working is made easier due to the
exceptionally large exit pupil and an increased stereo
base of 24 mm.
Please hold the lens tube with one hand while loosening
the screw. Otherwise the lens tube could drop.
• Loosen the screw on top of the lens tube and remove
the tubes from the microscope head.
• Make sure that the gudgeons and grooves of the dove
tail xation engage and the tubes lie at.
• Tighten the screw again.
• Check for a secure t.
4.12 Binocular rotary disk with detent
The rotary disk allows to raise the swivel tube at an angled
position of the microscope head and should therefore
simplify to look through the tubes. If the tubes are rotated
over the detent a loss of light or vignetting could occur.
4.13 Pivoting colour lter
The pivoting colour lter enhances contrast of the
microscopic picture for better visibility of vessel structures.
• Turn the function knob by 90° in clockwise direction to
swing in the colour lter.
• By turning the knob by 90° in an anti-clockwise
direction the lter is removed from the optical beam
path of the microscope.
Undo screw
Binocular angled lens tube 45°
Binocular straight
lens tube
Undo screw
Fine focussing
Pivoting colour lter
19
4.14 Shadowless illumination
The option shadowless illumination prevents instruments from causing shadows in the eld of view. This option cannot be retrotted.
• For the shadowless illumination no operating steps are required.
4.15 Microscope zoom and object eld size
Lens f in mm
equals the
approximate
working
distance
Factor display on the magnication unit Eyepieces with
lens tubes
f = 160 mm
0.5 0.7 1* 1.4 2.0
Total zoom / visual eld Ø in mm
200 4 / 50 5.6 / 35 8 / 25 11.2 / 18 16 / 12.5 10 x
250 3.2 / 63 4.5 / 45 6.4 / 31 9 / 22 12.8 / 16 10 x
300 2.7 / 75 3.7 / 54 5.3 / 38 7.5 / 27 10.7 / 19 10 x
400 2 / 100 2.8 / 70 4 / 50 5.6 / 36 8 / 25 10 x
* Read off at factor 1 when using the microscope zoom without the zoom unit.
4.16 Measuring scale
Via a small turning knob beneath the lens a true to scale dimension scale can be faded into the eld of the illumination light
path. This documentation display enables the measurement of objects regardless of the selected magnication. The scale will
be displayed in both the 3D picture and on all camera pictures and if required it can be faded out at any time.
• To fade-in the scale turn the knob by 45° in a clockwise direction.
• Via a 45° rotation in anti-clockwise direction the scale can be faded out from the path of illumination.
The following measures have to be observed: - Distance 2 mm, - Line width 0.5 mm
Please note that these specications are only correct for the following combinations: Measuring scale for 200 mm lenses, 200
mm lenses with or without ne focusing or wide angle eyepieces 10x
4.0 Operation
Measuring scale
0.5 mm
2 mm
10 mm
20 mm
2 mm
5 mm
Figure not true to scale
This gure is for guidance
only and may not be used
for measuring absolute
quantities.
20
MODE
LED
AFD
STROBO
LED STROBO AFD
4.17 Image and video recording
Integrated camera: If desired an SD camera or a HD
camera can be integrated in the ATMOS
®
i View 31 PRO.
External video sources: External video sources can be
controlled via the panel buttons if they are connected to the
jack plugs “Freeze” and “Record”.
Control panel buttons:
Save image.
Start / stop the recording of a video frequency
Adjusting the light mode of the integrated HD camera.
The data are transmitted to a connected PC (USB interface).
The ATMOSoft software can process the data.
Only with an integrated HD camera:
You can change between the integrated HD camera and
external video source by switching the LED light on or off.
As soon as the LED light goes off the integrated camera is
switched off and the data from the external video source is
displayed (Video Out 1 - 3).
Also observe this within the automatic light switching.
4.17.1 Adjusting the light mode of the integrated HD
camera
By pressing the MODE button once the current light mode
of the integrated HD camera is displayed on the monitor.
By pressing the MODE button again the light mode can be
changed.
Light mode Display on the monitor
Standard LED light remains unchanged.
When the power is switched on, the default
setting is automatically selected.
Center LED light will be displayed with less reec-
tions.
Suitable for recordings through an ear
speculum.
Warm LED light appears warmer.
4.0 Operation
21
4.18 Endoscope adapter
The standardized endoscope adapter allows for an easy
connection to an external ATMOS Cam or other external
endoscope or digital camera (third party products). The
ATMOS Cam can be easily and swiftly attached to the
endoscope adapter by means of a special clip seal.
Other endoscope cameras which provide a standardised
connection interface can also be adapted without any
trouble. To attach an external digital camera a special
adapter (which is suitable for the respective digital
camera) is required.
4.19 HD adapter
Due to the especially developed HD adapter it is possible
to connect a SONY digital camera with e-mount bayonet
to your ATMOS
®
i View PRO. This camera enables you to
take and archive HD resolution pictures.
At dispatch the HD adapter is covered with a cover cap.
This cap is to protect against contamination and has to be
re-attached at any time e.g. if the camera is removed or
when the adapter is unused.
Please make sure that externally connected cameras do
not exceed a weight of 300 g.
4.0 Operation
22
5.0 Cleaning and care
5.1 General information on cleaning and disinfection
Prior to cleaning
Medical devices like the ATMOS® i View PRO must be fail safe at all times. Therefore we recommend
prior to every use:
if required
5.2 Cleaning the mechanical microscope surface
All mechanical surfaces of the ATMOS® i View PRO must be wiped and disinfected after each application.
Do not use aggressive or abrasive cleansing agents.
Residues can be removed with a mixture made from equal parts of ethyl alcohol and distilled water to which a drop of standard
washing-up liquid is added.
If uids penetrated the ATMOS
®
i View PRO it needs to be sent in and may only be used after the check up of an ATMOS
authorised person.
Disconnect the plug from the mains current prior to cleaning and disinfecting the microscope surface.
For a sterile covering of the device the single-use sterilization drapes may be used. The sterilization drapes may only be used
once. Afx the cover loosely so that there is enough room left for the microscope support and the unit. The drapes must be
especially loose around the hand grips as the physician must be able to use the operating elements though the cover.
5.3 Cleaning of lenses / eyepieces
5.3.1 Cleaning optical surfaces
The multilayer T* coating of optical components (e.g. eyepieces, lenses) results in optimum image quality.
Image quality could be reduced even by the slightest contamination of the optics or by ngerprints. In order to protect the
internal optics from dust, the instrument should never be left without a safety cover, HD adapter, lens, binocular tube or
eyepiece installed when it is not in use.
After use the microscope should be covered in order to protect it from dust. Always store lenses, eyepieces and accessories
which are not being used in clean, dust-free cases.
The external surfaces of optical components should only be cleaned when required.
• Dust which has accumulated on the optical surfaces can be blown off or removed with a soft, clean brush.
5.3.2 Optical surface of the endoscope connection
The endoscope connection is protected against contamination and humidity by an end glass cover. This glass cover must
also be cleaned like the other optical surfaces of the ATMOS
®
i View PRO. This can be done by following the instructions for
cleaning optical surfaces.
On delivery the endoscope connection is protected with a cover against contamination and humidity. If you do not use the
endoscope connection over a long period of time, reattach this cover to protect it.
!
!
) The described action relating to cleaning and disinfection
resp. sterilisation do not substitute the relevant
instructions which must be adhered to prior to operation!
• All disinfectants used for the disinfection of the ATMOS
®
i
View PRO must be approved.
) Always observe the concentration specications and
instructions by the respective manufacturer!
23
5.0 Cleaning and care
5.3.3 Fogging of optical surfaces
To prevent the eyepiece optics from fogging, we recommend using an anti-fogging agent.
Note:
Anti-fogging agents used by opticians for eyeglass lenses are also suitable for the ATMOS
®
i View PRO.
• Please observe the instructions supplied with each anti-fogging agent.
Anti-fogging agents do not only ensure fog-free optics they also clean and protect them against dirt, grease, dust, uff and
ngerprints.
5.4 Recommended surface disinfectants
When using disinfectants containing aldehyde and amine at the same object colour changes may occur.
Do not use
- Disinfectants which contain organic or inorganic acids or bases as they could cause corrosion damage.
- Disinfectants which contain chloramines or phenol derivatives as they could cause stress cracks in the material which is used
for the housing.
Disinfectant
Suitable for
Microscope Handle Control unit Other mechanical sur-
face treatment
Optical surfaces
Green & Clean SK x x
Bacillol
®
30 Foam x
Kohrsolin
®
FF
(Application concentrate)
x x x
Kohrsolin
®
extra
(Application concentrate)
x x x
Mikrobac
®
forte
(Application concentrate)
x x x
Mikrozid
®
Sensitive Wipes x x
SaniCloth
®
Active x x
5.5 Hygiene Plan
WHAT HOW WHEN Details
C D S
after each
application
daily
weekly
monthly
Housing X X X Manual wiping and disinfection
Lens / Optics X X X Manual wiping and disinfection
Operation parts* X X X Manual wiping and disinfection
Protective covers
(disposables)
X
Single-use product -> not for reprocessing, change after use
Hand grips X X X Manual wiping and disinfection
C= Cleaning, D= Disinfection, S= Sterilization
* Operation parts
Knobs to adjust (colour lter, measuring scale, 5 fold magnication changer, operator panel, adjusting screws on the arm)
24
6.0 Maintenance and Service
6.1 General advice
• Prior to every use a visual inspection of the microscope and
microscope connection line must be performed. Damaged
cables must be replaced immediately!
• Maintenance, repairs and period tests may not be carried out
while the product is used on the patient.
• Maintenance, repairs and period tests may only be
carried out by persons who have the appropriate technical
knowledge and are familiar with the product. To carry out
these measures the person must have the necessary test
devices and original spare parts.
• ATMOS recommends: Work should be carried out by an
authorized ATMOS service partner. This ensures that repairs
and testing are carried out professionally, original spare parts
are used and warranty claims remain unaffected.
• At least every 24 months a repeat test of the electrical safety
should be performed according to IEC 62353. ATMOS
recommends an inspection according to the manufacturer‘s
specications.
• ATMOS neither guarantees for fault-free operation nor for
personal injuries and damage to property if
- no original ATMOS parts are being used,
- the advice for use in these operating instructions is not
being observed,
- assembly, new settings, alterations, extensions and
repairs have not been executed by ATMOS authorised
personnel.
+
...
+
...
Fuse exchange
• There are no warranty claims whatsoever on defects
or malfunctions which arise from the use of third party
accessories or consumables.
• The instructions and regulations for the respective eld of
application should be observed.
6.2 Sending in the device
• Remove and properly dispose of consumables.
• Clean and disinfect the product and accessories according
to the operating instructions.
• Place used accessories with the product.
• Fill in the form QD 434 „Delivery complaint / return shipment“
and the respective decontamination certicate.
) This form is enclosed to each delivery and can be found at
www.atmosmed.com.
• The device must be well padded and packed in suitable
packaging.
• Place the form QD 434 „Delivery complaint / return shipment“ and the respective decontamination certicate in an
envelope.
• Afx the envelope to the outside of the package.
• Send the product to ATMOS or to your dealer.
6.3 Exchange of spare parts
1
Brake star grip with copper REF 538.2013.0
2
Brake star grip with POM REF 538.2015.0
Fuse T 3.15 A/H 250 V REF 008.0751.0
Prior to exchanging the main fuse the system must be disconnected from the power supply. For this it is necessary to unplug the
power cord from the power outlet.
2
Microscope arm until 201412
1
2
Microscope arm since
2014-12
2
click
25
7.0 Troubleshooting
Description Possible causes Remedy
ATMOS
®
i View PRO cannot be
switched on
Mains cable is not connected
Defect fuse
Connect mains cable
exchange fuse
ATMOS
®
i View PRO is hot
Please ensure sufcient air ventilation.
Switch off and let cool down for 2-3 hours
ATMOS
®
i View PRO is
overheated
Please contact the ATMOS service.
No function whatsoever ATMOS
®
i View PRO is switched off
Switch on the ATMOS
®
i View PRO at the
connection box.
5-fold magnication changer is
defective
Contact the ATMOS service.
Arm follows
Tie bar is not vertically adjusted
The coverings of the set screws are
worn out or not xed into place
Adjust tie bar,
Exchange or x the extensions of the set screws
Contact the ATMOS service.
Too little or no light at all
The ATMOS
®
i View PRO was moved
into „parking position“ and thereby the
light was switched off.
Pull ATMOS
®
i View PRO into working position.
Malfunction of the LED light source
Contact the ATMOS service
Extreme decline in the LED light source.
Light source
Light source is dimmed down too low. Increase brightness of the light source.
Screen displays text.
Only with an integrated HD camera:
Button „mode“ has been pressed for a
longer time
Press button „mode“ once again
26
8.0 Options and Accessories
Lens
REF
Lens 200 mm 538.1000.0
Lens 250 mm 538.1100.0
Lens 300 mm 538.1200.0
Lens 400 mm 538.1300.0
Lens 200 mm with manual ne focussing (17 mm) 539.1700.0
Lens 250 mm with manual ne focussing (17 mm) 539.1800.0
Lens 300 mm with manual ne focussing (17 mm) 539.1900.0
Lens 400 mm with manual ne focussing (17 mm) 539.2000.0
VarioFocus lens (200-350 mm) 538.4000.0
Lens tube
REF
Binocular straight tube 10-times, f = 160 mm 538.3900.0
Binocular straight tube 16-times, f = 160 mm 605.2000.0
Binocular swivel tube 0-220°, f = 160 mm 538.9200.0
45° adaption for binocular tubes 606.1106.0
Binocular rotary disk with detent 538.3300.0
Cable (only for the ATMOS
®
i View 31)
REF
S-VHS cable professional, 5 m (not with an integrated HD camera) 008.0882.0
Cable HDMI type A/C, L = 5 m (only with an integrated HD camera) 538.1902.0
Cable HDMI extension, L = 5 m (only with an integrated HD camera)
008.0909.0
USB cable A/B, L = 5 m (only with an integrated SD camera) 008.0910.0
Accessories
REF
LogiLink, VG0001, USB 2.0 video grabber with audio function 534.1200.0
Consumables
REF
Sterile microscope cover, 10 pcs. 539.2206.0
27
9.0 Technical data
Voltage 100-240 V~ ± 10 %; 50/60 Hz
Power consumption max. 45 VA
Fuses 2 x T 3.15 A / 250 V
Operation time Continuous operation
Light intensity
F 200 min. 120 kLux
F 250 min. 80 kLux
F 300 min. 55 kLux
F 400 min. 30 kLux
Colour temperature 5000 K ± 500 K
Cooling Fanless / passive
Protective earth conductor resistance
Earth leakage current
Enclosure leakage current
Patient leakage current
max. 0.1 Ω
max. 0.5 mA
max. 0.1 mA
max. 0.1 mA
Ambient conditions transport / storage
Temperature -10...+50°C
Humidity without condensation 30...95 %
Air pressure 500...1060 hPa
Ambient conditions operation
Temperature +10...+35°C
Humidity without condensation 30...95 %
Air pressure 700...1060 hPa
Maximum operational altitude ≤ 3000 m
Contamination level 2
Overvoltage category II
Weight 3.65 kg - 5.6 kg
Period tests Repeat test of the electrical safety every 24 months.
Recommended: inspection according to the manufacturer‘s
specications.
Safety class (EN 60601-1) l
Degree of protection No application part available
Safety type IP X0
Classication according to Appendix IX EC Directive
93/42/EEC
Class l (according to regulation no. 12)
CE marking CE
GMDN code 35191
UMDNS code 12-536
ID No. (REF) 538.9000.0, 539.9000.0
Issue of the Technical Data: 20.12.2017
28
10.0 Disposal
• The ATMOS® i View PRO does not contain any hazardous materials.
• The housing is recyclable.
• Pay attention to a careful separation of the different materials.
• Please observe national disposal regulations (e.g. waste incineration).
Disposal within the EC
The device described above is a high-quality medical product with a long service life. After its life cycle it must be disposed of
professionally. According to the EC directives (WEEE and RoHS) the device may not be disposed of in domestic waste. Please
observe existing national laws and rules for disposal of old devices in the respective country.
Disposal within the Federal Republic of Germany
In the Federal Republic of Germany the law for electrical devices (ElektroG) regulates the disposal of electrical devices. It must be
assumed that these devices could be contaminated. Therefore, according to the regulations of the EAR (Stiftung Elektro-Altgeräte
Register) is this type of device excluded from the ElektroG regulations. In order to guarantee a proper disposal of your old device,
please either pass on your old device to your specialised dealer or send it directly to ATMOS MedizinTechnik for a professional
disposal.
Before disposal respectively before transport, the device surface must be disinfected.
29
11.0 Notes on EMC
11.1 Guidelines and Manufacturer´s Declaration - Emissions
The ATMOS® i View PRO is intended for use in the electromagnetic environment specied below. The customer or user of the
ATMOS
®
i View PRO should ensure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
RF Emissions acc.to CISPR 11 Group 1 The ATMOS
®
i View PRO uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.
RF Emissions acc.to CISPR 11 Class B
The ATMOS
®
i View PRO is suitable for use in all establishments,
including domestic and those directly connected to the public
low-voltage power supply network that supplies buildings used for
domestic purposes.
Harmonic emissions according to
IEC 61000-3-2
Class A
Flicker IEC 61000-3-3 Corresponds
11.2 Guidelines and Manufacturer´s Declaration - Immunity
The ATMOS® i View PRO is intended for use in the electromagnetic environment specied below. The customer or user of the
ATMOS
®
i View PRO should ensure that it is used in such an environment.
Immunity Test IEC 60601- Test Level Compliance Level Electromagnetic Environment - Guidance
ESD IEC 61000-4-2 ± 6 kV Contact
± 8 kV Air
± 6 kV Contact
± 8 kV Air
Floors should be wood, concrete, or ceramics
tile. If oors are synthetic, the relative humidity
should be at least 30 %.
EFT IEC 61000-4-4 ± 2 kV Mains
± 1 kV I/Os
± 2 kV inapplicable for
power cables
± 1 kV I/Os
Mains power quality should be that of a typical
commercial or hospital environment.
Surges IEC 61000-4-5 ± 1 kV differential mode
2 kV
Common
± 1 kV differential mode
2 kV
Common
Mains power quality should be that of a typical
commercial or hospital environment.
Magnetic eld at power
frequency 50/60 Hz acc.
to IEC 61000-4-8
3 A/m applicable
3 A/m
Power frequency magnetic elds should be that
of a typical commercial or hospital environment.
• Medical electrical equipment is subject to special precautions with regard to EMC and must be installed acc. to following EMC
notes.
• Portable and mobile HF communication facilities can inuence medical electrical equipment.
• The use of other accessories, other converters and cables than stated may lead to an increased emission or a reduced
interference immunity of the equipment or system.
30
11.0 Notes on EMC
Immunity Test IEC 60601- Test Level Compliance Level Electromagnetic Environment - Guidance
Voltage Dips, dropout
and uctuations in the
supply voltage acc. to
IEC 61000-4-11
< 5 % UT
(> 95 % Dip of the UT)
for 0.5 Cycle
40 % UT
( 60% Dip of the UT)
For 5 cycles
70% UT
( 30 % Dip of the UT)
For 25 cycles
< 5 % UT
( 95 % Dip of the UT)
for 5 s
< 5 % UT
(> 95 % Dip of the UT)
for 0.5 Cycle
40 % UT
( 60% Dip of the UT)
For 5 cycles
70% UT
( 30 % Dip of the UT)
For 25 cycles
< 5 % UT
( 95 % Dip of the UT)
for 5 s
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the ATMOS
®
i View PRO requires continued
function during interruptions of the energy
supply, it is recommended to supply the ATMOS
®
i View PRO from an uninterruptible power supply
or a battery.
NOTE UT is the alternating mains voltage prior to application of the test levels.
11.3 Guidelines and Manufacturer´s Declaration - Immunity
The ATMOS® i View PRO is intended for use in the electromagnetic environment specied below. The customer or user of the
ATMOS
®
i View PRO should ensure that it is used in such an environment.
Immunity Test
IEC 60601- Test
Level
Compliance Level Electromagnetic Environment - Guidance
Conducted RF IEC
61000-4-6
V1 = 3 Veff
150 kHz to 80 MHz
3 V
Portable and mobile communications equipment should
be separated from the ATMOS
®
i View PRO incl. the
cables by no less than the distances calculated/listed
below.
Recommended distances:
d = (3.5 / V1) * √(P)
d = [ 3,5 / E1 ] √P from 80 MHz to 800 MHz
d = [ 7,0 / E1 ] √P from 800 MHz to 2500 MHz
where „P“ is the max. power in watts (W) and D is the
recommended separation distance in meters (m).
Field strengths from xed transmitters, as determined by
an electromagnetic site (a) survey, should be less than
the compliance level (b).
Interference may occur in the vicinity of equipment
containing following symbol:
Radiated RF IEC
61000-4-3
E1 = 3 V/m
80 MHz to 2.5 GHz
3 V/m
31
11.0 Notes on EMC
11.4 Recommended safety distance between portable and mobile RF Communications
equipment and the ATMOS® i View PRO
NOTE 1 By 80 MHz and 800 MHz the higher frequency range applies.
NOTE 2
These guidelines may not be applicable in every case. The emanation of electromagnetic waves is affected by absorption and
reection of buildings, objects and people.
a
The eld strength of stationary transmitters, such as base stations of radio telephones and land mobile radio devices, amateur
radio stations, AM and FM radio broadcast and TV broadcast cannot be accurately predicted theoretically.
To determine the electromagnetic environment in regard to stationary transmitters, a study of the location is to be considered.
If the measured eld strength at the location where the ATMOS
®
i View PRO is used exceeds the above compliance level, the
ATMOS
®
i View PRO is to be observed to verify the intended use. If abnormal performance characteristics are noted, additional
measures might be necessary, e. g. a changed arrangement or another location for the ATMOS
®
i View PRO.
b
Within the frequency range of 150 kHz to 80 MHz the eld strength should be below 3 V/m.
The ATMOS
®
i View PRO is intended for use in electromagnetic environment in which radiated disturbances are controlled. The
customer or user of the ATMOS
®
i View PRO can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF Communications equipment and the ATMOS
®
i View PRO as recommended below, according to
the maximum output power of the communications equipment.
Safety distance, depending on transmit-frequency m
Nominal output of the
transmitter
W
150 kHz to 80 MHz
d = [ 3.5 / 3] √P
80 MHz to 800 MHz
d = [ 3.5 / 3] √P
800 MHz to 2.5 GHz
d = [ 7.0 / 3] √P
0.01 0.12 0.12 0.233
0.1 0.37 0.37 0.74
1 1.16 1.16 2.33
10 3.69 3.69 7.38
100 11.66 11.66 23.33
For transmitters for which the maximum nominal output is not indicated in the above table, the recommended safety distance d in
meters (m) can be determined using the equation belonging to the respective column whereas P is the maximum nominal output
of the transmitter in watts (W) acc. to manufacturer´s specication.
NOTE 1 By 80 MHz and 800 MHz the higher frequency range applies.
NOTE 2
These guidelines may not be applicable in every case. The emanation of electromagnetic waves is affected by absorption and
reection of buildings, objects and people.
ATMOS MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Straße 16
79853 Lenzkirch / Germany
Phone: +49 7653 689-0
atmos@atmosmed.de
www.atmosmed.com
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